Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

88 results found

Title
Status

 

NMTRC012 - A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Open

NMTRC012 - A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma

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DiagnosisNeuroblastomaStudy StatusOpen
PhaseII
AgeChild, Adult - (up to 22 Years )RandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationDFMO - oral Other drugs are given as usually administered for neuroblastoma therapy
Last Posted Update2024-03-19
ClinicalTrials.gov #NCT02559778
International Sponsor
Giselle Sholler
Principal Investigators for Canadian Sites
CHU Ste-Justine – Dr. Pierre Teira
CHU Quebec - Dr Bruno Michon
CHU Sherbrooke - Dr. Josée Brossard
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact
Dr. Josee Brossard 
Social worker/patient navigator contact
Please Contact Site Directly
 
Clinical research contact
Please Contact Site Directly 
 

 

 

Study Description

This study is to assess the effectiveness of molecular targeted therapy (four different possible medications) in addition to standard therapy for patients with a new diagnosis of high-risk neuroblastoma. The study also looks at the side effects associated with these medications.

The study also tests the effects of a drug called DFMO when added to the immunotherapy given as post-consolidation treatment.

Inclusion Criteria
  • Age 1 to 22 years
  • New diagnosis of high risk neuroblastoma
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

BCC018 - A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Open

BCC018 - A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

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DiagnosisHigh-risk NeuroblastomaStudy StatusOpen
PhaseII
Age12 Months to 21 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationDrug: Naxitamab (Intravenous (IV)) Additionally for patients with ALK aberration: Drug: Ceritinib (Oral)
Last Posted Update2024-03-19
ClinicalTrials.gov #NCT05489887
International Sponsor
Wake Forest University Health Sciences
Principal Investigators for Canadian Sites
CHU Quebec - Dr.Bruno Michon
CHU Ste Justine - Dr. Pierre Teira
Centres
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

This is a Phase 2 trial for newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of combining the drug naxitamab with standard induction therapy. Initially, there will be 5 cycles of standard chemotherapy with Naxitamab on days 1, 3 and 5 of each cycle. Patients with an ALK mutation or amplification will have the drug ceritinib added to their treatment regimen as soon as results are available. 

Inclusion Criteria
  • Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma that meets criteria
  • Subjects must be age ≤ 21 years at initial diagnosis
  • Subjects must be >12 months of age at enrollment
  • Subject's bloodwork must be within acceptable study ranges
  • Pregnant subjects are not eligible for this study, a negative serum pregnancy test is required for female participants of childbearing potential
  • Both male and female study subjects who have reached puberty must be willing to use a highly effective contraceptive method, these methods will be discussed with you by the study team
  • All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.
  • Subjects enrolled on study must complete all required assessments 

ADVL1921 (A5481092) - PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS

Closed to enrollment

ADVL1921 (A5481092) - PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS

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DiagnosisEwing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma, Diffuse Intrinsic Pontine GliomaStudy StatusClosed to enrollment
PhaseII
Age2 Years to 20 YearsRandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Palbociclib (Oral) Chemotherapy with Temozolomide (Oral or Intravenous (IV)); Irinotecan (Intravenous (IV))
Last Posted Update2024-03-19
ClinicalTrials.gov #NCT03709680
International Sponsor
Sponsor: Pfizer
Collaborator: Children's Oncology Group (COG)
Principal Investigators for Canadian Sites
CHU Ste-Justine - Dr. Monia Marzouki
The Hospital for Sick Children - Dr. Daniel Morgenstern
Alberta CH - Dr. Victor Lewis
Stollery Children's Hospital -
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault

 

 

Study Description

This trial studies the combination of a study drug called palbociclib with chemotherapy in children with solid tumors that have come back or not responded to standard treatment. Throughout this trial, the study team will observe how the drug is moving through your body and how your body is responding to the drug. The study team will also do a series of tests to study whether or not the drug is effective.

 

Inclusion Criteria
  • Patient must be between 2 years to 20 years old at time of treatment
  • Must have measurable disease of a solid tumour that has come back or has not responded to previous standard treatment 
    • For Phase 2 part, must have a diagnosis of Ewing sarcoma specifically 
  • Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures related to the study
  • Patient must be able to be up and about more than 50% of their waking hours
  • For patients of child bearing potential, they must not be pregnant or get pregnant during the course of the study

Other inclusion and exclusion criteria may apply and will be reviewed by your team

BCC015 - Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Open

BCC015 - Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

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DiagnosisNeuroblastomaStudy StatusOpen
PhaseII
AgeChild, Adult - (up to 31 years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationEtoposide: oral DFMO: oral
Last Posted Update2024-03-19
ClinicalTrials.gov #NCT04301843
International Sponsor
Giselle Sholler
Principal Investigators for Canadian Sites
Montreal Children's Hospital – Dr. Sharon Abish
CancerCare Manitoba – Dr. Ashley Chopek
CHU Ste-Justine – Dr. Pierre Teira
Alberta Children's Hospital – Dr. Melanie Finkbeiner
CHU de Quebec - Dr. Bruno Michon
Janeway Hospital – Dr. Paul Moorehead
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

 

 

Study Description

This study is to assess the effectiveness of a drug called Difluoromethylornithine (DFMO) in combination with etoposide for patients with neuroblastoma that has come back, or is not responidng to current treatment. DFMO is a medication taken by mouth. It is an blocker of ornithine decarboxylase, an enzyme involved with polyamine biosynthesis in the cancer cells, including neuroblastoma cells. 

Inclusion Criteria
  • Patients less than 31 years of age 
  • Diagnosis of neuroblastoma that has come back or is not responding to treatment 
  • Patients can have active or no active disease at the time of study start
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

 

ARST1921 - A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014) in Children and Adolescents With Progressive, Surgically Unresectable Desmoid Tumors

Closed to enrollment

ARST1921 - A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014) in Children and Adolescents With Progressive, Surgically Unresectable Desmoid Tumors

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DiagnosisUnresectable, Recurrent Desmoid FibromatosisStudy StatusClosed to enrollment
PhaseII
Age12 Months to 18 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Nirogacestat (given orally)
Last Posted Update2024-03-19
ClinicalTrials.gov #NCT04195399
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Victor Lewis
Montreal Children's Hospital - Dr. Sharon B. Abish
CancerCare Manitoba - Dr. Ashley Chopek
Stollery Children's Hospital -
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault

 

 

Study Description

This phase II trial studies how well the drug nirogacestat works in treating patients between the age of 1 to 18 years old with desmoid tumours that have grown after prior treatment and that cannot be removed by surgery. Nirogacestat works by blocking some of the chemicals that play a role in the growth of tumor cells. 

Inclusion Criteria
  • Patient must have a desmoid tumor that is existing or that has come back (recurrent) and that cannot be removed by surgery
  • Patients must be between 12 months to 18 years old 
  • At minimum, patients must be up and about at least 50% of their waking hours 
  • Blood work must come back within the acceptable ranges
  • Patients must have adequate heart function 
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • Your study doctor will discuss with you the medications you can and cannot take

Other inclusion and exclusion criteria may apply 

NMTRC014 - NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

Open

NMTRC014 - NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

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DiagnosisNeuroblastomaStudy StatusOpen
PhaseII
AgeChild, Adult - (1 Year to 30 Years )RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDFMO - oral Other drugs are given as usually administered for neuroblastoma therapy.
Last Posted Update2024-03-19
ClinicalTrials.gov #NCT02679144
International Sponsor
Giselle Sholler
Principal Investigators for Canadian Sites
CHU Ste-Justine - Dr. Pierre Tiera
CHU de Quebec - Dr. Bruno Michon
CHU Sherbrooke - Dr. Josée Brossard
Montreal Children's Hospital – Dr. Sharon Abish
Alberta Children's Hospital – Dr. Melanie Finkbeiner
CancerCare Manitoba – Dr. Ashley Chopek
Janeway Hospital - Dr. Paul Moorehead
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 
Medical contact
Dr. Josee Brossard 
Social worker/patient navigator contact
Please Contact Site Directly
 
Clinical research contact
Please Contact Site Directly 
 

 

 

Study Description

This study uses a drug called Difluoromethylornithine (DFMO) for patients with neuroblastoma in remission to assess the effectiveness of preventing recurrence. The study also looks at the side effects associated with these medication. DFMO is a medication taken by mouth. It is an blocker of ornithine decarboxylase, an enzyme involved with polyamine biosynthesis in the cancer cells, including neuroblastoma cells. 

Inclusion Criteria
  • Patients less than 30 years of age, with high-risk neuroblastoma in complete remission. 

M13-833 - A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

Closed

M13-833 - A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

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DiagnosisALL AML all solid tumoursStudy StatusClosed
PhaseI
AgeChild, Adult - (Up to 25 years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationOral tablet or suspension (Venetoclax) IV Chemotherapies
Last Posted Update2024-03-18
ClinicalTrials.gov #NCT03236857
International Sponsor
AbbVie
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern
CHU Ste-Justine- Dr. Henrique Bittencourt
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

Venetoclax is a medication, taken by mouth, which selectively binds and blocks a molecule called BCL-2, restoring the ability for natural cell death in cancer cells that have the BCL-2 marker. It is expected to slow or stop the growth of cancer cells.

The aim of this study is to evaluate the dose, safety, tolerability, antitumor activity and other characteristics of venetoclax given with or without chemotherapy.

Inclusion Criteria
  • Participants must have cancer that has come back or is not responding to current therapy
  • Age up to 25 years
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

OZM-075 - Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers

Closed

OZM-075 - Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers

Go to Health Care Provider version

DiagnosisRefractory or Recurrent Hypermutated Malignancies, Biallelic Mismatch Repair Deficiency (bMMRD) Positive Patients, Other solid tumours, CMMRDStudy StatusClosed
PhaseI/II
AgeChild, Adult - (12 Months to 18 Years)RandomisationN/A
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIV
Last Posted Update2024-03-18
ClinicalTrials.gov #NCT02992964
International Sponsor
The Hospital for Sick Children
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern
BC Children's Hospital - Dr. Rebecca Deyell
Centres
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

Some cancer, called hypermutant cancer, have been shown to have multiple genetic changes  or abnormalities that block DNA repair and favor tumour development. Nivolumab is a human monoclonal antibody that binds and blocks PD-1 on tumors cells.  The PD-1 pathway is an immune system checkpoint that may be used by cancer tumour cells to help them trick the immune system (escape surveillance) and avoid being destroyed. By blocking the PD-1 pathway, nivolumab reactivates cells from the patient immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

In this phase I/II study, patients will not be randomized and all enrolled on the clinical trial will receive nivolumab.  The study will evaluate the dose, safety, tolerability, effect on the cancer and other important characteristics of nivolumab.  This study includes pediatric patients with recurrent or refractory hypermutant cancer aged 12 months to 18 years, including those with  bMMRD syndrome. for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

Inclusion Criteria

•    Patients must be greater than 2 months and less than 25 years of age at time of enrollment. Please note, some hospitals may not be able to treat patients above certain ages (e.g., 18 years old).
•    Recurrent or relapse paediatric cancer suspected to be hypermutant, including those exhibiting evidence of genetic or molecular alterations such as: high microsatellite instability (MSI-H) in current or previous tumour, mutation causing loss of mismatch repair gene (MLH1, MSH2, MSH6, PMS2, EPCAM or MSH3) expression, hypermutation by local sequencing in current or previous tumour, a history of CMMRD, Lynch syndrome, xeroderma pigmentosum (XP), or other established disorder affiliated with an elevated hypermutation rate, a functional mutation of polymerase genes (POLE or POLD1) in current or previous tumour, a functionally impaired RRD pathway by other means; etc. 
•    Patients must have histologic or cytologic confirmation of malignancy at the time of initial diagnosis or relapse (as specified above). Patients with multiple concurrent and/or sequential neoplasms are eligible, including CNS and haematological malignancies.
•    Patients must be able to provide tumour sample (archival or a new biopsy). If a tumour sample (including archival) is not available, a new tumour sample may be needed. Any such biopsy will not be considered a trial-related procedure.

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.